Sedation and analgesia for pediatric fracture reduction in the emergency department: a systematic review

Migita RT, Klein EJ, Garrison MM

CRD summary

The review concluded that ketamine hydrochloride-midazolam hydrochloride was associated with less distress and significantly fewer airway interventions during paediatric fracture reduction than fentanyl citrate-midazolam or propofol-fentanyl. Data comparing other forms of sedation or analgesia were limited. The authors' conclusions reflect the evidence presented, but their reliability is uncertain due to potential language bias and small sample sizes for some studies.

Authors' objectives

To assess the safety and efficacy of sedation and analgesia for fracture reduction in paediatric patients in the emergency department.

Searching

MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL were searched to April 2005 for English-language studies. Search terms were reported. Reference lists of other trials and review articles were scanned for additional articles. Medical Editors' Trial Amnesty was searched for unpublished trials.

Study selection

Randomised controlled trials (RCTs) that compared pharmacological methods of sedation or analgesia for fracture reduction in paediatric patients (18 years or less) in the emergency department were eligible for inclusion. The primary outcomes of interest were pain scores of patients who underwent fracture reduction; secondary outcomes were surrogate measures of pain (provider, patient or parent satisfaction; patient memory of event; procedural success; requirement of additional medication doses); and adverse events.

The main types of sedation-analgesia included in the review were varying doses of lidocaine hydrochloride or prilocaine hydrochloride, ketamine hydrochloride, midazolam hydrochloride, propofol, fentanyl citrate, morphine sulphate, ketorolac tromethamine, meperidine hydrochloride, promethazine hydrochloride and 50% nitrous oxide. Methods of administration included bier block and intravenous. Participants' age ranged from two year to 18 years. A range of outcomes were reported, most frequently pain measured using the Observational Score of Behavioural Distress-revised (OBSD-r), visual analogue scale (VAS) and subjective pain scores of patient, parent or provider; other outcomes were patient recall, sedation time/scores and recovery time.

Two reviewers independently assessed articles for inclusion. Disagreements were resolved through discussion with a third reviewer.

Assessment of study quality

Only RCTs where randomisation was deemed adequate were included in the review. Blinding was not considered a suitable criterion due to the nature of sedation modalities. Three reviewers independently assessed validity.

Data extraction

Data on relevant outcomes were extracted independently by two reviewers.

Methods of synthesis

Studies were grouped by type of sedation-analgesia and combined in a narrative synthesis. Additional data were reported in tables.

Results of the review

Eight RCTs (n=1,086) were included in the review. Sample sizes ranged from 28 to 283.

Patients treated with ketamine-midazolam compared with fentanyl-midazolam, reported significantly reduced OSBD, parental reported pain and anxiety, and orthopedists’ satisfaction (one RCT, n=260). In another RCT (n=113) patients who received ketamine-midazolam treatment had significantly longer sedation and recovery time than patients treated with propofol-fentanyl.

Patients treated with 3mg/kg lidocaine bier blocks compared to 1.5mg/kg lidocaine bier blocks reported significantly less pain (one RCT, n=283), particularly when the fracture was completely displaced. Another RCT (n=249) reported significantly less pain for patients who received 3mg/kg lidocaine bier blocks compared to those who received 3mg/kg prilocaine. There were no significant differences in pain for patients who received 50% nitrous oxide compared with lidocaine bier block (one RCT, n=24) or meperidine with promethazine (one RCT, n=30). Patients treated with nitrous oxide had a significantly shorter total procedure time than those who received bier block with lidocaine (one RCT) or meperidine (one RCTs).

Adverse events: One RCT (n=260) reported patients treated with ketamine-midazolam were less likely to have hypoxia, need breathing cues or require oxygen than those who received fentanyl-midazolam, but vomiting was more common in the ketamine group. Patients who received ketamine-midazolam had significantly fewer desaturation events and required fewer airway manoeuvres than those who received treatment with propofol-fentanyl (One RCT, n=113).

Further results were reported in the review.

Authors' conclusions

Patients treated with ketamine hydrochloride-midazolam hydrochloride experienced less distress and required significantly fewer airway interventions during paediatric fracture reduction than patients who received fentanyl citrate-midazolam or propofol-fentanyl. Data that compared bier blocks with systemic forms of sedation or analgesia were limited.

CRD commentary

The review question and inclusion criteria were adequately described. Several relevant sources were searched and some efforts were made to reduce publication bias. The restriction to English-language studies meant there was potential for language bias. Appropriate methods were used to reduce reviewer error and bias. A limited validity assessment was conducted and only RCTs with adequate randomisation were included in the review; blinding was considered an inappropriate criterion due to the nature of the interventions. A narrative synthesis was appropriate given the differences between studies in terms of interventions and outcomes. The authors appropriately reported limitations of the review, which included small sample sizes for some treatments. The authors' conclusions reflect the evidence presented, but their reliability is uncertain due to potential language bias and small sample sizes for some studies.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that future research should utilise a validated pain scoring system (such as Children's Hospital of Eastern Ontario Pain Score, OSBD-r or Procedure Behaviour Checklist) to enable more comparisons between studies. Future studies should comparatively evaluate the effectiveness of ketamine, etomidate, propofol and nitrous oxide.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.